Process and Systems Validation

What Is Process and Systems Validation?

Process and Systems Validation is the documented procedure of verifying that a process, system, or piece of equipment in the pharmaceutical industry operates reliably, consistently, and in accordance with established regulatory standards. The core purpose of this validation is to provide objective evidence that the system or process consistently produces a result or product that meets its predetermined specifications and quality attributes.

This is essential for ensuring regulatory compliance, particularly with Good Manufacturing Practices (GMP), and guaranteeing the safety, efficacy, and quality of the final pharmaceutical product.

What Process and Systems Validation Do We Perform?

We offer comprehensive validation services that are compliant with GMP and GAMP standards and tailored to the lifecycle of each product and system. Our services include:

Process Validation

We validate a wide range of critical manufacturing and packaging processes to ensure they are robust and repeatable.

• Validation of manufacturing processes for solid, semi-solid, and liquid forms.
• Validation of conditioning and packaging processes.
• Validation of cleaning processes to prevent cross-contamination.

Transport Validation

We perform transport validation to ensure that product integrity is maintained throughout the supply chain, guaranteeing data integrity and control over automated systems.

Computerised System Validation (CSV)

We ensure that your computerised systems are fit for their intended purpose and meet regulatory requirements. Our CSV services include:

• Development of the Validation Plan (VP).
• Advisory services for drafting User Requirement Specifications (URS).
• Comprehensive Risk Analysis (RA).
• Drafting and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Creation of final reports and all necessary GMP documentation.

What Are the Benefits of Process and Systems Validation?

Engaging in thorough Process and Systems Validation provides significant advantages that are crucial for success in the pharmaceutical sector. Key benefits include:

• Ensures Regulatory Compliance: Provides the documented evidence required to meet stringent standards set by regulatory bodies like the FDA and to adhere to GMP/GAMP guidelines.
• Guarantees Product Quality: Confirms that manufacturing and control processes are consistent, reliable, and capable of producing a high-quality product batch after batch.
• Minimises Risks: Proactively identifies and mitigates potential issues within manufacturing, data handling, and automated systems before they can affect the final product or lead to costly recalls.
• Optimises Processes: Leads to more efficient, robust, and consistent production cycles, which helps to reduce waste and strengthen your overall Quality Management System (QMS).

Why Choose Applus+ Laboratories for Process and Systems Validation?

Applus+ Laboratories is a trusted partner for the pharmaceutical industry, delivering technical solutions that drive quality and compliance. Our approach combines deep technical knowledge with extensive experience in highly regulated environments. We are committed to excellence, helping our clients achieve their goals with efficient, compliant solutions.

• Deep Technical Knowledge: We possess extensive expertise in pharmaceutical processes and validation standards.
• Regulatory Experience: Our team has a proven track record of working within highly regulated environments like GMP and GAMP.
• Client-Centric Solutions: We focus on minimising risks and optimising processes to meet your specific needs.
• Commitment to Excellence: We are dedicated to providing reliable, efficient, and safe validation services.

We leverage an international network of multidisciplinary laboratories to support the development, validation, and certification of our clients' products. Our commitment to reliability, efficiency, and safety allows us to provide high-value technical solutions that help you achieve your business objectives and ensure market success.